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Trial · NCT01857310

Registered outcomes38

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryLive BirthAt deliveryBased on hospital delivery records
PrimarySemen Volume6 months
Volume of the ejaculate, mL Assessed utilizing the World Health Organization (WHO) semen analysis procedure 5th edition World Health Organization. WHO laboratory manual for the Examination and processing of human semen. 5th Edition ed. Switzerland: 2010.
PrimarySperm Concentration6 months
Number of spermatozoa per unit of volume of semen Assessed utilizing the World Health Organization (WHO) semen analysis procedure 5th edition World Health Organization. WHO laboratory manual for the Examination and processing of human semen. 5th Edition ed. Switzerland: 2010.
PrimarySperm Motility6 months
% motile (including percentage of progressive motile sperm and percentage of nonprogressive motile sperm) Assessed utilizing the World Health Organization (WHO) semen analysis procedure 5th edition World Health Organization. WHO laboratory manual for the Examination and processing of human semen. 5th Edition ed. Switzerland: 2010.
PrimarySperm Morphology6 months
% normal morphology Assessed utilizing the World Health Organization (WHO) semen analysis procedure 5th edition World Health Organization. WHO laboratory manual for the Examination and processing of human semen. 5th Edition ed. Switzerland: 2010.
PrimaryDNA Fragmentation Index6 months
Comet assay used to measure sperm DNA integrity based on excess DNA strand breaks Assessed utilizing the World Health Organization (WHO) semen analysis procedure 5th edition World Health Organization. WHO laboratory manual for the Examination and processing of human semen. 5th Edition ed. Switzerland: 2010.
PrimaryTotal Motile Sperm Count6 monthsCalculated as semen volume (mL) \* sperm concentration (10\^6 spermatozoa/mL) \* motility (% motile)
SecondaryHuman Chorionic Gonadotropin (hCG) Detected Pregnancy (Implantation)
For IVF, 12 days post embryo transfer for day 5 embryo transfers, and 14 days post embryo transfer for day 3 embryo transfers; for couples undergoing OI/IUI, after self-report of positive pregnancy test
A quantitative hCG evaluation in serum \> 5 milli-international units per milliliter (mIU/ml)
SecondaryClinical Intrauterine Pregnancyapproximately 6.5 weeks gestationVisualized gestational sac in the uterus on ultrasound
SecondaryEctopic Pregnancyapproximately 6.5 weeks gestation
Either visualization of no gestational sac in the uterus with a suspicious mass in the adnexa on ultrasound, an hCG level more than 1500 mIU/ml without visualization of an intrauterine gestational sac on ultrasound, or a slowly rising or plateauing serum hCG level without visualization of an intrauterine gestation on ultrasound.
SecondaryEarly Pregnancy LosshcG-detected pregnancy until 20 weeks of pregnancy
hCG pregnancy loss will be defined as a serum hCG \> 5 mIU/ml followed by a decline. Clinically recognized pregnancy losses will be defined as visualization of an intrauterine gestational sac followed by a loss prior to 20 weeks gestation.
SecondaryPreeclampsia or Gestational HypertensionDeliveryAbstracted from hospital records and medical charts
SecondaryGestational DiabetesDeliveryAbstracted from hospital records and medical charts
SecondaryCesarean DeliveryDeliveryAbstracted from hospital records and medical charts
SecondaryPreterm DeliveryDeliveryAbstracted from hospital records and medical charts
SecondarySmall for Gestational AgeDeliveryAbstracted from hospital records and medical charts
SecondaryGestational AgeDeliveryAbstracted from hospital records and medical charts
SecondaryBirth WeightDeliveryAbstracted from hospital records and medical charts
SecondaryStillbirthDeliveryLoss at or after 20 weeks gestation. Determined based on hospital records and medical chart abstraction.
SecondaryNeonatal MortalityDeliveryAbstracted from hospital records and medical charts

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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